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CLOZAPINE از شرکت MYLAN

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CLOZAPINE از شرکت MYLAN

Abbreviated New Drug Application (ANDA): 201824

Company: MYLAN

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CLOZAPINE CLOZAPINE 12.5MG TABLET, ORALLY DISINTEGRATING;ORAL None (Tentative Approval)

None

No No
CLOZAPINE CLOZAPINE 25MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription

AB

No No
CLOZAPINE CLOZAPINE 100MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription

AB

No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
09/15/2015 ORIG-2 Tentative Approval

Not Applicable

Label is not available on this site.

09/15/2015 ORIG-1 Approval

Not Applicable

Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/201824Orig1s000ltr.pdf

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/29/2021 SUPPL-15 REMS – MODIFIED – D-N-A

Label is not available on this site.

02/18/2021 SUPPL-13 REMS – MODIFIED – D-N-A

Label is not available on this site.

07/26/2020 SUPPL-11 Labeling-Package Insert

Label is not available on this site.

01/16/2019 SUPPL-9 REMS – MODIFIED – D-N-A

Label is not available on this site.

11/17/2017 SUPPL-7 Labeling-Package Insert

Label is not available on this site.

01/22/2016 SUPPL-5 Labeling-Package Insert

Label is not available on this site.

01/22/2016 SUPPL-4 Labeling-Package Insert

Label is not available on this site.

CLOZAPINE

TABLET, ORALLY DISINTEGRATING;ORAL; 25MG

TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CLOZAPINE CLOZAPINE 25MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 090308 BARR LABS INC
CLOZAPINE CLOZAPINE 25MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 201824 MYLAN

TABLET, ORALLY DISINTEGRATING;ORAL; 100MG

TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CLOZAPINE CLOZAPINE 100MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 090308 BARR LABS INC
CLOZAPINE CLOZAPINE 100MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 201824 MYLAN
بخوانید  CLOZAPINE از شرکت AUROBINDO PHARMA LTD
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